Product Questions

VSL#3is a patented combination of live lactic acid bacteria probiotics that have been cultivated, freeze-dried and mixed in high concentration (hundreds of billions per gram).

VSL#3is the probiotic that has been proven in clinical studies to be effective in serious gastro-intestinal disorders, and in particular in the management and preventions of pouchitis. Pouchitis, an inflammation of the small bowel reservoir or pouch, is the most frequenet long-term complication following colon removal and pouch creation surgery for ulcerative colitis.

VSL#3has the highest possible concentration of bacteria. Each packet of VSL3 contains 450 billion live lactic acid bacteria. This high number is necessry to ensure the establishment of lactic acid bacteria in the gut andf trigger the desired effects in the intestinal tract.

VSL#3science speaks for itself. 8 strains of bacteria have been purposefully selected, carefully cultivated and mixed proportionately to obtain the proven experimental and clinical effects ofVSL#3:

Bifidobacterium breve

Bifidobacterium longum

Bifidobacterium infantis

Lactobacillus acidophilus

Lactobacillus plantarum

Lactobacillus casei

Lactobacillus bulgaricus

Streptococcus thermophilus

Probiotic Medical Food As a probiotic medical food, VSL#3® is specially formulated and processed to provide a precise mixture of certain bacterial species with potential synergistic relationships. The importance of the gastrointestinal microflora in the normal functioning of the human gastrointestinal tract is well recognized12-15. Several studies demonstrate that patients with IBS, UC or an ileal pouch have decreased luminal concentrations of lactobacilli and bifidobacteria compared with healthy individuals16-23. Patients with IBS, UC or an ileal pouch may benefit from consuming high levels of probiotic bacteria so as to maintain the appropriate quantity and balance of beneficial microflora in their gastrointestinal tract. This is particularly important for patients with UC or an ileal pouch in view of their frequent and often long term antibiotic treatment. Hence, IBS, UC and ileal pouch patients have a distinct nutritional requirement that differs from normal individuals. Daily consumption of high levels of probiotic bacteria is needed to maintain adequate and balanced colonization in the gastrointestinal tract, and this cannot be achieved simply by modification of the normal diet.

Clinical studies have shown thatVSL3probiotics can be taken safely for long periods of time without any problems. Adjustment of the intestinal flora afterVSL3administration can take a few days or weeks and it can take up to a month for the colonization of the gut to become optimally stable.

Safety

Probiotics, including the strains in VSL#3®, have a long history of safe use in foods34. The safety of VSL#3® is well established by the substantial historical use of the contained microorganisms in fermented dairy products35,36. Many probiotic species are integral to the production of fermented foods and have been consumed safely as part of these foods for millennia15. Furthermore, many bifidobacteria and lactobacilli species are normal, nonpathogenic inhabitants of the human gastrointestinal tract, oral cavity, skin, and vagina15,37-39. While theoretically probiotic species could act as opportunistic pathogens, epidemiological surveillance data indicate that the risk of infection from consumption of lactobacilli is negligible35,40. In the available literature, documented cases of infection attributable to probiotic treatment are rare and limited to case reports. These case reports are primarily associated with patients having compromised immune systems or other major health problems41-45. Each strain of probiotic bacteria in VSL#3® is both non-pathogenic and non-toxigenic. The use of these particular strains in VSL#3® medical foods has been confirmed as generally recognized as safe (GRAS)56 for use in foods. The lactic acid bacteria in VSL#3® have a long history of use in foods. Studies of VSL#3® have been conducted in several animal models of colitis and inflammatory liver disease46-51, 56. In experimental animal models of colitis, there are serious derangements in epithelial permeability and barrier function, causing the animals to be particularly vulnerable to bacterial translocation. These studies demonstrate that VSL#3® normalizes gut permeability and barrier function52-54. Thus, despite increased gut permeability and inadequate barrier function the probiotics contained within VSL#3® do not translocate from the gut lumen and act opportunistically when ingested by animals with colitis.

VSL#3® products are manufactured in accordance with Current Good Manufacturing Practice for foods, using ingredients that are listed by the U.S. Food and Drug Administration (FDA) as food or food additives, or are “Generally Recognized as Safe” (GRAS)56 food substances. The lactic acid bacteria in VSL#3® have a long history of use in foods15,34.

Allergen Status

All formulations of VSL#3® contain none of the following: wheat, gluten (other cereals), soy, milk (including lactose), crustacean shellfish, eggs, peanuts, nuts, fish, celery, mustard, sesame seeds, sulfur dioxide and sulfites (>10 mg/kg), lupin, mollusks. VSL#3® contains cornstarch, an inactive ingredient, which is generally well-tolerated.GMO Status All formulations of VSL#3® do not consist of, nor contain, nor are produced from genetically modified organisms according to the definitions of Regulation (EC) 1829/2003 and Regulation (EC) 1830/2003 of the European Parliament and the Council of 22 September 2003.

All formulations of VSL#3® are Kosher and Halal-certified.

Interactions with other medications

VSL#3® is believed to be compatible with most types of drugs. If taken with antibiotics, VSL#3® should be consumed in-between antibiotic doses thereby maximizing the probiotic effect.

Side Effects

Mild abdominal bloating has been reported in the first few days of consuming VSL#3®. This is usually a transitory phenomenon due to the changing intestinal microflora. If you experience bloating, you may need to reduce your daily intake to allow for this adjustment.

VSL3 is a high potency probiotic formula made up of eight different strains of live bacteria that have been carefully cultivated and mixed in a ratio that maximizes the probiotic content. The highest number of bacteria and the unique choice of strains gives VSL3 a dramatic degree of potency.

It has been said that VSL#3 capsules are about 10-100 times* more potent than the average probiotic.[*Source: AC Nielsen, Dec. 2009. Average bacteria claimed by product manufacturers was between 1 and 10 billion per capsule or tablet]

VSL3is the probiotic proven effective in controlled clinical trials.

VSL3contains 8 beneficial strains acting like a 'Living Shield'. When comparing other available products, you should consider the number of strains and the total bacteria.

VSL3is reasonabley priced when considering the number of lactic acid bacteria you get per dollar.

Adult intake: VSL#3® is designated for the dietary management of UC, an ileal pouch and IBS. Daily intake ranges from 225 to 3,600 x 109 CFU. Consuming VSL#3® has been shown to aid in the dietary management of UC in both adults and pediatric patients. VSL#3® has been found useful following IPAA surgery for UC. It has also been shown to reduce symptoms in mild pouchitis, and to reduce relapse of pouchitis symptoms following antibiotic-induced remission. VSL#3® may also decrease bloating and flatulence in patients with IBS.

Pediatric Intake: VSL#3® is also designated for the dietary management of UC or IBS in children. VSL#3® was the first probiotic medical food to be utilized in a pediatric, randomized, placebo-controlled, double-blind, crossover trial that suggested the safety and efficacy of a highly concentrated mixture of probiotic bacterial strains in active UC and demonstrated its role in maintenance of remission4. For children, the amount consumed per day varies by age, weight and clinical study6-11, 55.

Storage

VSL#3® consists of live, lyophilized bacteria. It should be stored at a cold and stable temperature. VSL#3® products if unopened and stored under refrigeration (36-46°For 2-8°C), are guaranteed through the “Best if used by” date. VSL#3® can be stored at room temperature (77°F) for up to 2 weeks without having a major effect on potency. If it is left at room temperature for longer periods of time or exposed to excessive heat, the number of beneficial bacteria in VSL#3® can become greatly reduced. Studies have not been conducted on the effects of freezing on VSL#3®. But repeating changes in temperature such as freezing, refrigerating and refreezing can stress the bacterial cell membranes, which are vital to the life of the bacteria. Therefore, VSL#3® can be stored until needed in the freezer, but once it has been frozen and then thawed, it should then be maintained at refrigeration temperature and not be refrozen.

Crohns.net - Good Gut Solution's unique approach to complementary health care combines both Western and Eastern philosophies using products and techniques that promote long term benefits. Through education, behavior modification and supplementation, participants in our programs see remarkable improvements. We have over 30 years of successful experience in treating those suffering with diverse digestive conditions including Crohn's Disease, Ulcerative Colitis, Leaky Gut Syndrome, Dysbiosis and Irritable Bowel Syndrome (IBS).